Module C - Rules and Legislation

Recommended Prerequisites

The recommended prerequisites include what is taught in the 1 st cycle courses in the area of  Pharmacy, Medicine, Biology, Agricultural Sciences, Bioanalytical, Chemical Sciences, Chemistry, Biochemistry and other related courses.

Teaching Methods

Lectures with a strong component of dialogue and application in practical cases, essentially using the audiovisual media ("data show").

Learning Outcomes

Check knowledge about regulatory expertise in the area of drugs and other herbal health products, with emphasis on European legislation and in particular the Portuguese legislation.

Work Placement(s)

No

Syllabus

The program will be prepared annually in accordance with the appearance of emerging areas that fall within the educational project of the curricular unit.

Highlights for the following aspects: 

-international monographs on medicinal plants
- Regulatory aspects related to herbal drugs
- Marketing authorizations on herbal drug
- Regulatory aspects to other herbal health products

Head Lecturer(s)

Lígia Maria Ribeiro Pires Salgueiro da Silva Couto

Assessment Methods

Assessement
The evaluation of this curricular unit includes some mini tests and other continuous evaluation according to that defined by the teaching team.: 100.0%

Bibliography

Monografias internacionais de plantas medicinais (ESCOP, OMS, EMA, FE)

Documentos da EMA, INFARMED, UE e de outros outros organismos internacionais